Phase I Dose Escalation Study To Evaluate the Safety and Pharmacokinetic Profile of Tefibazumab in Subjects with End-Stage Renal Disease Requiring Hemodialysis

Abstract

Two cohorts of four subjects requiring hemodialysis received tefibazumab (10 or 20 mg/kg). The mean elimination half-life was between 17 and 18 days, the average volume of distribution was 7.3 liters, and the average clearance was 12 ml/h for both dose groups. At a dose of 20 mg/kg of body weight, plasma levels were 88 microg/ml at 21 days.